Remote Speech Analysis in HF Patients Undergoing Haemodialysis

NCT ID: NCT03714126

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2021-03-08

Brief Summary

This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

HF patients

HF patients will use the Cordio Medical app to record in their hospital visits and at home.

Cordio Medical

Intervention Type: DEVICE

Recording to an app, no interference to the regular care

Interventions

Cordio Medical

Recording to an app, no interference to the regular care

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
• Class C Heart Failure patient with reduced EF CHF (EF<40%) and NYHA 2-3.
• Patients with dyspnea clinically related to pulmonary congestion
• Patient with more than 3 months HF disease duration.
• The patient is willing to participate as evidenced by signing the written informed consent.
• Male or non-pregnant female patient

Exclusion Criteria

• Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
• Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
• Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4.
• Patients with evidence of active Infection.
• Patient with severe alcohol or drug use.
• Psychological instability, inappropriate attitude or motivation.
• Patient with life threatening debilitating disease other than cardiac.
• Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordio Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ittamar Gork, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Ein Kerem

Locations

Hadassah Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

CLN0014

Identifier Type: -

Identifier Source: org_study_id